Patient Engagement: Practical Approaches for Emerging Biotech CMOs

Kalliopi “Kali” Stasi, M.D., Ph.D. is a renowned expert with over 20 years of experience in ophthalmology specializing in clinical development for gene and cell therapy. She is currently Adverum’s Senior Vice President of Clinical Development and acting CMO responsible for global strategic planning and execution of the clinical development programs of gene therapy for age related macular degeneration. Most recently, Dr. Stasi served as the senior vice president, clinical development and acting CMO at Tenpoint Therapeutics, leading clinical development for cell therapy for age-related macular degeneration and other ophthalmology indications. Prior to Tenpoint, Dr. Stasi served as an early clinical development leader at Novartis Institutes for Biomedical Research for more than 8 years, leading the gene and cell therapy ophthalmology pipeline including the first AAV internally generated, gene therapy program, plus low molecular weight compounds for various indications. Previously, she was associate professor of Ophthalmology at University of Pennsylvania for 4 years, combining a busy medical and surgical anterior segment ophthalmology practice with cutting edge translational research on stem cell therapies.Dr. Stasi earned her M.D. and Ph.D. in Neurodegenerative Diseases from the University of Patra, Greece. She completed ophthalmology residency at the University of Rochester NY, and a Cornea and Refractive Surgery Clinical fellowship at Johns Hopkins Wilmer Eye Institute. She also completed a post-doc glaucoma research fellowship at Mount Sinai (including work on complement that led to the Lewis Rudin Award from the NY Academy of Medicine) and completed a business post-baccalaureate degree at Wharton Business School.

Jessica Scott, MD, JD, is a Patient Engagement leader who brings to Legacy Health Strategies a combined acumen of medicine and law, together with innovative thinking allows her to drive culture change in medical product development within organizations which results in mutually beneficial outcomes for patients and industry. She is also an experienced ambassador for medical policy issues and patient engagement to organizations and agencies on a global level. Dr Scott is known as a credible and trusted thought-leader and collaborator, bringing novel solutions, digital strategies, and patient-centered approaches to biotech, med tech and pharmaceutical industries and across multi-stakeholder groups. Dr Scott has deep knowledge of the pharmaceutical industry with senior leadership positions at both GlaxoSmithKline and Takeda where her focus has been on building patient perspectives into the process of R&D, enhancing trust and fostering a sense of true partnership with patients. She leads by inspiring others and engendering high levels of engagement with skillful, timely, and consistent delivery of initiatives and solutions that bring more medicines of value to patients, faster. Dr Scott has received awards for innovative and impactful work in Patient Engagement including the Trail Blazer Award and PharmaVoice100 as one of the top 100 most inspiring leaders in the industry. She is actively involved as a strategic advisor to Bioethics International, Patient Focused Medicines Development, DIA Patient Advisory Council and remains actively licensed to practice law in North Carolina where she also practiced as a Family Physician for over a decade.

Arun Balakumaran, MD, Ph.D., is Replay's Chief Medical Officer. With a proven track record of leading teams and an innate ability to prioritize and solve complex challenges, Arun consistently delivers outstanding results. As an MD, Ph.D., and board-certified specialist in Hematology and Medical Oncology, Arun combines his extensive medical knowledge with a Master's in Healthcare Management. His passion for immune therapies and cell and gene therapy has guided his career from laboratory research to clinical development across phases 1 to 4. Arun has demonstrated exceptional leadership throughout his journey, securing breakthrough designations and overseeing successful registration experiences. Most recently, he was the CMO of Allogene, where he led the programs to a pivotal stage in heme malignancy and proof of concept data in solid tumors with gene-edited allogeneic CAR T cells. Before joining Allogene, Arun held the position of Distinguished Scientist and Product Development Lead, Hematological Malignancies at Merck. There, he played a pivotal role in driving the approval of Pembrolizumab in lymphomas. Arun's expertise and insights have also led to his involvement on the scientific advisory boards of diagnostic companies. Arun's thought leadership is evident through his extensive publication record. He has authored over 40 peer-reviewed articles in esteemed journals such as Blood, Stem Cells, Journal of Clinical Oncology, and Nature Medicine. With his wealth of experience and expertise, Arun is poised to make significant contributions as the CMO at Replay, leading the way in driving innovation and success in the field of genomic medicine.

Charlotte Guzzo is the Co-Founder and COO of Sano Genetics, a 360° platform that combines genetic testing, recruitment, and long-term engagement, accelerating enrollment and simplifying operations for precision medicine teams driving breakthroughs for patients.

Wendy Harman is a dynamic leader in healthcare innovation, specializing in the biopharmaceutical and diagnostics sectors. With over two decades of experience in product development and commercial strategy, she has established herself as a trusted expert in new product planning, commercial and patient insights and launching groundbreaking products. She currently is serving as the Vice President of Product/Marketing at Tasso Inc. Throughout her career, Ms Harman has played a pivotal role in driving innovation and delivering impactful products to patients worldwide. Her extensive commercial expertise has been instrumental in helping guide R&D functions and clinical development teams through the drug development cycle to ensure new products are focused to deliver on the unmet needs of patients. Her passion for advancing patient care extends beyond the boardroom. She is deeply committed to fostering patient engagement and empowering healthcare leaders to prioritize patient needs in their strategic initiatives. As a guest on the Patient Engagement: Practical Approaches panel, Ms Harman brings a wealth of expertise and strategies to patient engagement to the table. Her focus and approach for driving positive change and fostering meaningful patient insights will encourage attendees to rethink their approach to asset development to embrace patient-centered models.